Hypertension
Conditions
Keywords
cerebral blood flow, positron emission tomography, magnetic resonance imaging, neuropsychology
Brief summary
Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one has more favorable effects on brain blood flow and cognitive function.
Detailed description
The project examines the neuropsychological status, peripheral blood flow, and structural cortical (magnetic resonance imaging, MRI) and functional cortical blood flow (quantitative positron emission tomography, PET) status of previously unmedicated hypertensives. These individuals are then medicated for one year with one of two effective blood pressure medications. Our hypothesis is that the angiotensin-converting enzyme inhibitor, but not the beta-blocker will normalize cerebral blood flow and possibly, cognitive function. This hypothesis is tested by a repetition of our initial examinations at the completion of one year of treatment.
Interventions
DRUGAtenolol (drug), Lisinopril (drug)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All subjects will be between 35 and 65 years of age, and must have a diastolic BP between 90 and 109 mm Hg, systolic BP between 140 and 179 mm Hg, or both. Eligibility will be based upon readings taken at two screening visits. For resting BP determinations, eating, smoking, drinking and heavy physical activity will be proscribed for 1 hour prior, and drinking caffeinated beverages 2 hours prior. Systolic and diastolic (5th phase) BP will be determined twice separated by 2 minutes using a 2-3 mm Hg/sec deflation rate. Before readings, a 60 s resting pulse will be obtained. Two readings over two such sessions will be averaged. All measurements will be obtained by individuals certified in BP measurement by the Department of Epidemiology of the Graduate School of Public Health. Potential subjects must have either no prior pharmacologic treatment for hypertension or minimal lifetime exposure. The latter is defined as no more than 6 months of blood pressure medication within the past 5 years. No blood pressure medication taken at all in the 6 months preceding study enrollment. To establish medical eligibility and to screen for secondary causes of hypertension, subjects will provide a medical history and have their standard blood chemistry determined to screen for occult renal failure and primary hyperaldosteronism. All women will be postmenopausal or tested (urine specimen) to ensure the absence of pregnancy. To ensure their ability to complete the behavioral assessments, subjects must have at least an 8th grade education and immigrants must have spoken English as their primary language for at least five years.
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral blood flow in response to working memory task | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological function | — |
Countries
United States
Outcome results
None listed